Device for the resection of bones, method for producing such a device, endoprosthesis suited for this purpose and method for producing such an endoprosthesis

ABSTRACT

The present invention refers to a device for the resection of bones ( 1 ) for preparing the attachment of an endoprosthesis to the joints which consists of at least two joint elements cooperating with each other, comprising at least one tool guide ( 3, 4, 5, 7, 14 ) and at least one support ( 6, 9, 10, 15, 21 ) suitable for orienting the at least one tool guide ( 3, 4, 5, 7, 14 ), wherein, either in the immediate vicinity of the joint and/or across joints, the at least one support ( 15, 21 ) enables the at least one tool guide ( 3, 4, 5, 7, 14 ) to be oriented and positioned on a further joint element, or enables the at least one tool guide ( 3, 4, 5, 7, 14 ) to be oriented and positioned at the same joint element distally to the area to be treated and/or outside the surgical area. The at least one tool guide ( 3, 4, 5, 7, 14 ) and the at least one support are preferably immovably connected to each other so as to manufacture an individual single-use template. The invention also relates to a method for manufacturing such a device or template, an endoprosthesis suited for this purpose, a method for manufacturing such an endoprosthesis, and a surgical set consisting of said parts.

The present invention relates to a device for resection of bone,particularly to the preparation of the mounting of an endoprosthesis, amethod for manufacturing such a device, an appropriate endoprosthesis, amethod for manufacturing such an endoprosthesis and a surgery set,consisting of these components, and which is particularly suitable forperforming knee joint surgery. Such devices present tool guide, forexample for wielding a scalpel for resection of a bone as well assupports, which position and adjust the tool guide relatively to thebone.

According to state of the art, it has been well known for many years towork with templates as implantation aid, for example with traditionalknee joint surgeries, whereas generally, these templates consist ofmetal and are assembled from a wide range of instruments and scalpelapparatus which are very complex and delicate in some cases, and whichrequire a multitude of adjustments and measuring steps during surgery inorder to achieve a precise adjustment of tool guide, such as scalpelguidance, for ensuring the exact resection of the bone and formaintaining the proper fit of the prosthesis. Generally, the surgeonmust go through extensive training, and during surgery, he has toperform a multitude of strenuous adjustment and measuring proceduresunder the highest level of concentration.

For example, under DE 4 434 539 C2 methods have been described by whichan image of the damaged bone, such as a damaged knee joint, is madebefore the actual surgery by using computer tomography or magneticresonance imaging. These pre-operative images could be adjustedaccordingly, while conducting an approximation of the contours of thedamaged bone to the contours of a healthy bone. After such a correction,a virtual post-operative image of the damaged bone is made, which offersa direct comparison with the pre-operative image. From this comparison,a subtraction image is made which allows the manufacturing of theendoprosthesis. With it, the natural contour of the bone is approximatedas precisely as possible.

From EP 1 074 229 A2, it is known to separate the damaged bone areasvirtually with the help of a tomographic image, first of all, in whichthe separation is made on marked cut surfaces. As a result, pictorialmodels are obtained which are proximately oriented on the damaged bone,and can be virtually completed with the help of a healthy bonestructure, where applicable, and then, they can be used for themanufacturing of an endoprosthesis which is precisely adapted to the cutsurfaces and the natural bone structure. Simultaneously, these pictorialmodels are used for the manufacturing of an implantation aid, whichmeans that the cut surfaces are included in a template which is adaptedto the individual bone structure of the patient. These implantation aidscan be used for the implantation of individual endoprostheses accordingto EP1 074 229 A2 as well as conventional, standardized andnon-individually or only partly individually adjusted prosthesis.

From DE 42 19 939 A1, a template for appropriate tools for themodification of bony structures and a method defining the correlation ofthese tools to these bony structures are known, whereas first of all,only sectional images of the bony structure are made and athree-dimensional design of this structure and its surface is obtained.Subsequently, in the pre-operative planning stage, an individualtemplate is manufactured which rebuilds the surface of the bonestructure and will be applied to the exposed points of contact andcontact areas in order to guarantee a defined tool guide during surgery.

State-of-the-art templates and implantation aids which have beenmanufactured with the help of tomographic pictorial models and whichfeature tool guide, such as cutting edges and cutting cores as well asareas adapted to the bone structure for attaching the templates,partially have the disadvantage of a necessary adaption of the templatesduring surgery by additional extensive measurements of bone axes andligament tensions or of a precise adaption only being possible with amarking which had been attached to the bone pre-operatively. The reasonfor this is that the precise surface structure of the bones cannot beexactly determined in virtual environments due to physical limits atimage taking, for example because of soft tissues or bulges which cannotbe exactly defined in the images, contact-areas are over-determined andoversized areas are included which cause an extensive arithmetical andpartly manual effort at establishing data records as well as a templatethat cannot be adapted precisely and is loose. Therefore, most often itis necessary to pre-operatively attach appropriate pins or wires to thebone before three-dimensional pictures are taken. Afterwards, thetemplate will be attached to them.

By using such an individual template, the adjustment and measuringprocedures are shifted before surgery, even without the use of markersor pins. The templates are completed according to an image previouslyobtained by computer tomography, for example of the knee joint skeleton,in order for the guide cores of the saw blades to guarantee the idealresection areas for the prosthesis bed. After opening of the surgicalsite, precast templates will be positioned on the bone and enable animmediate resection of bone which provides a significant relieve for thesurgeon who can thus focus on other important details of surgery, suchas operational access, hemostasis and soft tissue management. As aresult, the implantation can be carried out in a more precise, secureand safe way than by use of conventional, reusable and partly adaptedindividually implantation aids or templates as described in the abovementioned publications.

Another disadvantage of the conventional implantation technique is thehigh expenditure of time needed for conduction the adjustment proceduresduring surgery which requires keeping the surgical wound open for longerand increases the risk of infection. Additionally, the so-calledtourniquet prevents the blood circulation of the extremities duringsurgery and damages soft tissue with increasing duration of surgery. Notleast, this results in a prolonged anaesthesia time for the patient andthus, an increased risk of surgery for thromboses, embolisms andcardiopulmonary complications, among other things.

Implantations performed with the required technique according to EP 1074 229 B1 reduce the required surgery time, on average by well abovehalf of the usual surgery time, on average, and put less strain on thepatient. Furthermore, reusable, non-individually adapted implantationinstruments have the disadvantage of a more extensive production,storage, maintenance and sterilization compared to individually producedsingle-way- or one-way-articles. Individual templates can bemanufactured from plastics, such as polyamide, as one-way-articleswhereas although production costs occur with each surgical intervention,their manufacture is increasingly cost-effective and faster due totoday's computer-assisted three-dimensional manufacturing techniques(such as “rapid manufacturing”). Furthermore, no costs for cleaning,sterilizing, storage, maintenance and controlling occur. Nevertheless,the disadvantage of the individually adapted templates is that theycannot always be manufactured pre-operatively in such a precise way inorder for the support, which generally consists of surface of thetemplate which is negatively shaped to the bone surface, to capture thebone surface exactly.

In the images taken pre-operatively, cartilage tissue, fibrocartilage orbone tissue cannot be clearly identified to some extent which createsthe possibility of a moving of the template upon applying on the boneand as a result, the tool guide is not found precisely in place wherethe bone needs to be prepared.

In the treatment of patients with knee joint endoprosthesis, the use oftemplates individually attached to the bone, as described in EP 1 074229 B1 or DE 42 19 939 A1, results in a shifting of the adjustment andmeasurement procedures from the operating theaters and hence, to asimplification of the surgery and a reduction of surgery time.

While this state-of-the-art technology fully describes the possibilityof a precise resection of bone and while a remark in these prints can befound which states that it opens the possibility of an extensivepreservation of the ligaments of the knee joints and accordingly abetter adaption of the ligamentous structures of the knee joints, thegenerally still necessary corrections of the ligamentous tension on theknee joint (soft tissue alignment) has not been mentioned in thisconnection because the use of conventional individual implementationaids does not provide relieve or benefits in the first place.

Generally, with the further advance of the arthritis of the knee jointin addition to the changes of the joint surfaces, a correspondingtransformation in the ligamentous structures takes place. In mostplaces, by inflammation a slight shrinkage or reduction of the ligamentsis caused, occasionally also a loosening in connection with a mechanicaloverwork takes place.

The most common instance of an arthrosis which primarily takes place inthe internal compartment of the knee joints leads to an impairment oreven destruction of the cartilage lining, predominantly of the internaltibia area and the internal femoral condyle with simultaneous shorteningof the ligamentous structures of the internal and rearward capsularligament apparatus. Because of the slight bow-leg deformities that areoften connected with it, an increased tension on the outer ligamentousapparatus continues along with it which occasionally loosens or changesslightly due to chronic, mechanical overload.

With a surgical replacement of the knee joint by a knee jointendoprosthesis, it is necessary to optimally reconstruct the mechanicalleg axis as well as to adjust the ligamentous tension as precisely aspossible in order to prevent an incarnation on one side and aninstability on the other side. This has to be achieved in the extensionposition as well as the flexion position of the knee joints.

The conventional methods, as for example, mention in the implantationdescription “Aesculap Orthopaedics Columbus, knee endoprosthesissystem”; prospectus no. O254 01 by the company Aesculap AG, are limitedto determining the mechanical axes precisely and performing theresection on the femur as well as on the tibia in order to straightenthe joint line horizontally in the frontal plane, with a contingentundefined, slight backward drop (slope) in the lateral plane andsubsequently, the ligamentous apparatus of the implanted prosthesis isadjusted in extension position and flexed position to this situation.

However, this method does not consider the joint line of the patientwhich plays an important role in terms of exact height, backwardstilting and the occasional lateral inward tilting, according to latestfindings.

Since this newly created joint line causes a complete change of thekinematic interaction of the joint surface and the ligaments, it isoften necessary to adapt the ligamentous tension for the stretchingposition and/or the flexing position while at the same time, not onlythe short ligament structures but also the healthy structures frequentlyhave to be corrected and the anterior cruciate ligament is regularly andthe posterior cruciate ligament is often removed. In many cases, theentire biomechanics experience a fundamental change which is an area ofconcern, especially in the interaction with the knee joint and which canbe quite painful for the patient after surgery.

At least, the implantation method according to EP 1 074 229 B1 takes thepatient-specific joint line into account, but here, too, the individualadapted knee joint endoprosthesis is too tight internally andaccordingly, the ligamentous apparatus is shortened and tightened aftera correction of the height defect of the tibia area and the femoralcondyle cause by arthrosis and mostly due to cartilage damage whichmakes a correction of the ligamentous tension necessary but only in thearea of the abnormal capsule tissue.

In the more rare cases where the outward capsule apparatus is loosenedby excessive mechanical demands, a slight overcorrection of the inwardligamentous apparatus is necessary; with a simultaneous increase of thetibia area (for this purpose, three tibia plateau heights with 1 mmheight increase each compared to the original height respectively theheight “plus one” are provided).

By this method, the repeated measuring and the repeated insertion andtesting of the prosthesis or of a trial implant are necessary, too. Thiswill be carried out by—as with other conventional implementationmethods—first implanting the thigh component or lower leg component(femural or tibial component) as cost-**effectively as possible,depending on the method (femur first or tibia first), and subsequentlyimplementing the resection for the second component by taking intoaccount the leg axis and the adjustment of the capsule ligamentapparatus at extension and diffraction.

The function of the invention is the specification of an appropriatedevice which simplifies the surgical procedure for the surgeon,minimizes the risk of error, shortens the length of surgery, minimizescosts and guarantees an exact adaption of the tool guide without theneed of extensive readjustment and, at the same time, makes allowancesfor the aforementioned, individual biomechanics of the patient.

Another function of the present innovation is the implementation of amethod for the manufacture of such a device as well as appropriateendoprostheses and methods for the manufacture of such endoprostheses.

These problems are solved by distinguishing features of the independentpatent claims 1, 10, 13, 15 and 17. Advantageous definitions of thepresent invention are identified in the subclaims and described there.Especially preferred embodiments of the present invention for thetreatment of knee joints, that is to say the tibia bone and the femurbone, are explained by use of the enclosed images.

The inventive device for the resection of bones for the preparation ofan attachment of an endoprosthesis to the joints which consists of atleast two jointly cooperating joint parts features at least one toolguide and at least one support appropriate for adapting for at least onetool guide whereas the support enables either the cross joint adjustmentand positioning of at least one tool guide at one further joint part ordistally to the area which needs to be prepared, and resected inparticular, and/or the adjustment and positioning of at least one toolguide on the same joint part outside the surgical area.

Outside the surgical area, the support according to a preferredembodiment can also take place on intact skin-soft tissue surfaces onthe same or the opposite joint part. Within the surgical area, a supporttakes place preferentially on the bone in immediate vicinity of the bonewhich needs to be resected on the same or the opposite joint part.

According to the invention after the resection of, for example, thethigh bone for the implantation of an endoprosthesis thigh component,for example, by use of an initial individual thigh bone template, firstof all, the support—in the form of a second template—is attached on, forexample, the thigh bone will need to be resected and prepared. Accordingto a preferred embodiment of the present invention, this inventivesupport consists of a 3-dimensional-restruction of the thigh prosthesiscomponents which needs to be implanted, made of, for example, polyamide.The resection device and accordingly the tool guide for the resection onthe lower leg bone adheres firmly to this inventive support, that is tosay, the thigh prosthesis component, for the manufacture of an implantbed for the lower leg bone component.

With the known height of the necessary endoprosthesis tibia components(tibia plateau), the distance between the underpart of the thighprosthesis components reconstruction and the cutting area, determinedwith the help of this tool guide, correspond exactly to the height ofthe endoprosthesis tibia components, so that a resection on the tibiabone which suits this prosthesis component perfectly is guaranteed, inany case.

With the help of so called distracters, such innovative templates enablean exact examination of the ligamentous tension before resection as wellas during extension and diffraction. For this purpose appropriate slotsare attached to the the joint area remote to the body (distal) and tothe backward (dorsal) joint area of the prosthesis components of thetemplate. Here, the ligamentous tension can be controlled and correctedwith the adjoining template and without removing it repeatedly regardingextension as well as diffraction.

However, it is important to consider that on the thigh prosthesiscomponent reconstruction of the template, that is to say the inventivesupport, the cartilaginous defect has already been corrected but thecartilaginous defect on the lower leg side is still existing becausethere, the original bone of the patient is still present and as a resultthe height defect of the tibia plateau needs to be corrected initiallyby introducing an appropriate placeholder until it is compensated by thereplacement with the tibia component of the endoprosthesis.

The height of the defect and accordingly the height for this placeholderis determined pre-operatively by means of the height difference betweenthe actual height of the patient's tibia plateau and the height of thetibia plateau of the tibia component which is approximately identicallyto the height of a healthy knee joint. This corrective measure can alsobe achieved by a correspondingly higher adjustment of the distracters tothe height of the cartilaginous defect which makes the use of aplaceholder unnecessary.

The leg axis can be continuously monitored by inserting a measuringstick into the openings or this inventive device or template providedfor this purpose. If the leg axis is adjusted correctly and theligamentous tension is sufficiently balanced in extension as well asdiffraction, the lower part of the template with the tool guide can besecured to the tibia by introduction of the so called Kirschner's wireinto the appropriate canals, and the resection can be done securely onthe determined area of the lower leg bone.

This cross-jointed adjustment and resection of each of the oppositejoint parts enable a simpler, more reliable and faster performance ofthis surgical step in comparison to the state-of-the-art techniques.

Occasionally, very contracted and tight ligaments are present witharthrotic knee joints which make it very difficult to adjust anappropriate template to the joint without conducting extensive softtissue solutions and therefore, causing damages to it In these cases,the reverse procedure is suggested (tibia first) where the tibia isresected initially in order to provide enough space in the joint. Thetibia resection takes place according to the invention by use of asupport which is distal to the area which needs to be resected and/orenables the adjustment and positioning of at least one tool guide on thesame joint part, thus, the tibia, outside the surgical area.

This inventive support enables a bony support, such as on the surgicallyopened tibial plateau by, for example, a sleeve-shaped support to theskin and the skin of the bone over the intact, distal shinbone. Thereby,a precise positioning of the template with regard to the tibial axis aswell is provided.

To be specific, a major problem is the precise positioning of theindividually adapted tibia template. Different from the thigh bone, thetibia area cannot be exposed so far that it can be partly covered with atemplate. Additionally, on the tibia, there are less so called“landmarks” where the template can be adjusted securely. Even thesmallest tilting can cause serious deviations from the planned resectionline.

With the template system used so far, only a bony support on thedissected tibia bone in the immediate vicinity of the tibia plateau—incase it can be uncovered—is used by employing, for example, punctual orlinear supports (DE 42 19 939 A1).

With the combination of a bony support on the tibia plateau—if it can bedissected that far—and a support outside the surgical situs, on thelower part of the tibia, with a support on skin and skin of the bone ofthe tibia which sit directly on the bone in this part of the body andtherefore, similar to exposed bones, provide a good counterfort fortemplates, such as shown in FIG. 11, an adequately secure and precisepositioning of the template and its cutting areas in the anglesindividually needed can be achieved due to the relatively long lever-armbetween the bone-supported template and the shinbone positioned farbelow.

This adjustment of a tibia template in immediate vicinity of the jointon the which has not yet been practiced according to state-of-the-arttechniques in immediate vicinity of the joint on the dissected bone and,at the same time, on the distal, far-flung tibia covered with a thinskin of the bone and skin layer, outside the surgical area, increasesthe precision and reliability of the positioning of the template and thebone cutting significantly.

When implanting knee joint total endoprosthesis, incorrect positioningwith small mistakes regarding diffraction or extension are toleratedrelatively well, therefore, only little attention has been paid to theadjustment of diffraction and extension. Within the scope of increasingdemands on implantation accuracy, especially regarding individuallyadapted endoprostheses and the preservation of cruciate ligaments, sucha device for controlling and correction is increasingly gaining inimportance.

The described methods for an axially adjustment of the components of theprosthesis as well as for the exact adjustment of the ligamentoustension can be implemented—with slight variations and in differentcombinations with the following—with features, as described in detailbelow, with conventional and also individually manufactured bicondylarand monocondylar knee joint endoprostheses. Furthermore, such templatescan be applied for the implementation of revision endoprostheses andtumor prostheses. These preferred features will be explained further:

The inventive device for the resection of bones, especially for thepreparation of adapting an endoprosthesis, preferably shows at leastanother support suitable for adaption of at least one tool guide whereasthe support is designed punctual or linear. At the same time it ispreferred that at least one of the tool guides as well as at least oneof the support devices is connected immovably, so that a resectionmaster plate is created from tool guide and the at least a punctual orlinear support device. Punctual for the purpose of this device meansthat small areas are affected which amount to less that 10% of thecomplete area each, preferably less than 5% of the complete area,especially preferred between 0.1% and 3% of the complete area as areafor supporting the bone or cartilage.

The tool guide and the support can each be manufactured as a separatecomponent of the resection template, which can be immovably connected atthe support by fastening devices like screws, braces or locks accordingto the adaption method which has been determined before surgery. In thisconnection, the tool guide can be manufactured from a more consistent,for example, a vitrifiable metallic material in series, for example, infive different sizes and then, be connected and adjusted repeatedly withdifferent, unmodified individually manufactured supports from plastics,for example, polyamide. This saves production cost.

The use of the “rapid manufacturing”-technology makes it possible tomanufacture individual resection templates which can be made under useof, for instance, computer tomographic data instead of a wide variety ofstandardized metal templates which can not be adjusted to the patient'sbone until the actual surgery is performed. For example, two resectiontemplates for the treatment of a knee joint—one for the femur and onefor the tibia—can be produced from, for example, polyamide,polyurethane, epoxy resin or suchlike, which means from a suitable andsterilized material appropriate for the “rapidmanufacturing”-technology.

For this purpose, the punctual or linear support is molded according totwo- or three-dimensional images of the bone which needs to be treated,such as tomographic images, whereas the linear shape of the support ismolded along defined surface structures of the bone or rather, thepunctual shape of the support is molded according to special surfaceareas of the bone according to two- or three-dimensional images. At thesame time, one or several tool guides can also be positioned and adaptedrelatively to the surface structure of the bone according to the two- orthree-dimensional image data so that a three-dimensional data record isgained which can be used for the manufacturing of templates.

According to a special embodiment of the present invention, severalinitial linear supports in several initial—basically parallel—levels arekept from each other at a distance and several second linear supports inseveral second—basically parallel—levels are kept from each other at adistance, whereas several initial and several second levels are notarrayed parallel to each other but basically rectangular to each other,so that a grid-shaped surface structure or supporting structure resultsfrom it which supports the template and accordingly the implantation aidwith the help of the bone during surgery. For this purpose,two-dimensional computer-tomographic images are appropriate which makeit possible to recognize the exact contour of the bone in the crosssection area. Precisely, these sectional images are implemented aslinear supports inside the template so that cavities between the linearor the punctual supports are worked into the templates, in whichexisting (not recognized) cartilage tissue, for example, fibrouscartilage or bone tissue can spread without disturbing the adjustment ofthe template and its adaption.

The rib construction at manufacturing of the linear supports has theadvantage that only precise landmarks of the bone are shown and workedinto the template whereas the effort of the reconstruction of the jointsurface negative is not only reduced but an exact and precise support onthe bone is guaranteed. Additionally, according to a special embodimentof the invention, the ribs can show an elasticity which compensatespossible inaccuracies of the surface depending on the material used andthe chosen rib thickness. Because of their elasticity, the ribs can bepushed aside by cartilages or soft tissue elevations not shown in theimages whereas the position of the template is clearly held in the rightposition by the mainly correctly resting rib sections. On clearly andeasy to define areas of the bone and cartilage surface, the rips canadditionally be strengthened, for example, by additional vertical ribtractions which are not parallel to the initial ones.

According to another embodiment of the present invention, at least onetool guide features a guidance depth which basically extends between thebone and the guide stops of the tool guide which means, in the case of acutting core, this would be the depth of the core of the template sothat an exact depth of resection according to a pre-defined immersiondepth of the tool is guaranteed. The guidance depth and the depth ofresection account for the immersion depth of the tool, which is thedepth of the template and the bone into the tool immerses. Because ofthe guide stop on the distal end of the tool guide, a precise immersiondepth of the tool and thus, a pre-defined depth of resection andprocessing depth is given.

The several grid-shaped, especially linear supports and the several toolguides which are angular to each other preferably build a resectiontemplate which can be advantageously molded from a cast or worked from amaterial in such a way that the template is seamlessly formed from onepiece. For the molding of the template, the aforementionedthree-dimensional image data is appropriate which is complementedcorrespondingly by the tool guides and the working areas on the bone.Therefore, the template which is individually adjusted to the bone doesnot only guarantee a precise adaption of each tool guide in relation toeach other, but also an exact positioning of the tool guide on the boneso that the separately manufactured endoprosthesis does not only fitexactly to the cut surface after resection but also approximateprecisely the original natural and healthy structure of the bone,especially its surface.

With this advantage, the template additionally has viewing openings orfixation openings in order to enable the surgeon the sight into thesurgical area during surgery or rather to additionally fix the templateto the bone, for example, in case the tool is used and a movement of thetemplate is suspected. Through these fixation openings, for example,screws, nails or wires can be inserted into the bone for the adjustmentof templates, whereas it is not necessary to define correspondingmarking areas on the bone because the exact positioning of the templateon the bone is already guaranteed by linear or punctual supports.

According to another embodiment of the invention, the template can alsodisplay other supporting areas or supports which can be connected toother body parts which take up a steady and immovable position towardsthe bone which needs to be prepared.

The inventive method for manufacturing a device for the resection ofbones with at least one tool guide and at least one support appropriatefor adapting at least one tool guide preferably displays the followingsteps:

-   -   1. Two- or three-dimensional images of the bone which needs to        be prepared on are taken or made. For this, radiographs or        resonance images are appropriate which show the bone which needs        to be prepared on in layers.    -   2. Subsequently, punctual and/or linear contours of the bone are        recognized in the two- or three-dimensional images. Suitable are        state-of-the-art rendering methods which automatically scan and        detect such contours due to shades of gray values.    -   3. Subsequently, the suitable tool guide is selected and        positioned by means of two- or three-dimensional images. The        positioning is conducted by means of determining the area which        needs to be prepared, so for example, it is determined at which        edge of the bone an area needs to be cut off. For this purpose,        a cut surface is defined for which a tool guide for guiding a        saw is positioned.    -   4. Finally, the template is manufactured with at least one        support which enables the adjustment and positioning of at least        one tool guide to another joint part in immediate vicinity of        the joint or cross jointed or enables the adjustment and        positioning of at least one tool guide to the same joint part        distal to the area which needs to be resected and/or outside the        surgical area. For this reason, at least one tool guide is        manufactured which is positioned and adjusted relatively to the        support. Suitable methods are the known “rapid        manufacturing”-technologies, in which the template can be molded        or formed from a suitable plastic or polymer blocks are worked        on with appropriate milling, cutting or drilling machines or a        combination of the aforementioned methods is used. This is        recognized as state-of-the-art technology.

For the production of a template, a three-dimensional data record isused, which includes the punctual and linear supports for the attachmentof the templates to the bone. The linear shape of the support occurspreferably along defined surface structures of the bones and the pointedshape occurs according to special area features of the bone which can bedetected with the help of two- and/or three-dimensional images.

According to a special embodiment of the present innovation, severalgrid-shaped, linear supports and several tool guides which are angularto each other are determined with the help of two- and/orthree-dimensional images, and subsequently, saved in a three-dimensionaldata record for the manufacturing of an inventive template. For theseamless manufacturing of the template, the supports and tool guides aremolded according to the three-dimensional data record.

After another preferred configuration of the present invention, thetemplate can be configured universally adjustable. For this purpose, thetemplate or the device is initially manufactured as described above,preferably from stainless steel and instead of rips, contact plates ondifferent, for example, nine different points of the femur, are adjustedwhich are adapted to the precise distance before the surgery by, forexample, bolt threads and which are locked in this position by anappropriate locking screw. The adjustment of the point-shaped supporttakes place in vitro, with the help of two- or three-dimensional images.Therefore, an adjustment during surgery is not necessary anymore but canstill me made, if desired. In terms of this invention, “immovable”relates to the tool guides and the supports.

If necessary, some screws need to be removed before bringing in the sawblades into the resection cores, because in this area, an intersectionof resection core and bolt thread can possibly not be avoided. Reusablefemur and tibia templates and femoral tibia templates are preferablykept ready in, for example, five different sizes in order to satisfy theindividual needs of the patient regarding height differences. Thereusable templates as well as the traditional surgical instruments arecleaned, sterilized and reused.

Furthermore, according to another embodiment of the present invention,devices for the attachment of sensors, such as a customary navigationsystem (for example Orthopilot® of the company Aesculap AG), can befixed to the template and with its help, the focus point of the femoralhead can be determined kinematically. With its help, the tibial axis canbe adjusted, for example, mechanically and/or with the help of anavigation system as well.

The present invention also applies to a method for the manufacturing ofan endoprosthesis for attaching to a bone which has been especiallyprepared with one of the aforementioned devices. The followingprocedural steps are appropriate:

-   -   1. Two- or three-dimensional images of the bone which needs to        be prepared are taken or already prepared two- or three        dimensional image data is used for the manufacturing of a device        for the resection of bone.    -   2. Subsequently, the areas of the bone which need to be prepared        are determined and the area which needs to be removed from the        bone is chosen and positioned.    -   3. Afterwards, a virtual correction of the two- or        three-dimensional images or the respective image data is carried        out in order to achieve an approximation of the contours of the        bone or the cartilage to the contours of a healthy bone or        cartilage. Thus, the image data is completed or changed in order        to achieve an “ideal bone or cartilage.”    -   4. Subsequently, an inventive template for the resection of bone        for the preparation of attaching an endoprosthesis to the joints        is manufactured which consists of at least two jointly        cooperating joint parts whereas the template is equipped with at        least one tool guide and at least one support which is        appropriate for the adjustment of at least one tool guide        whereas the support enables either a cross joint adjustment and        positioning of at least one tool guide on another joint part or        enables the adjustment and positioning of at least one tool        guide to the same joint part distal to the area which needs to        be resected and/or outside the surgical area.    -   5. Finally, the endoprosthesis is manufactured according to the        areas of the bone or cartilage which need to be prepared and the        virtual correction of the two- or three-dimensional image data.        In particular, the endoprosthesis is adapted molded according to        the cut surfaces of the bone or cartilage as well as the outer        contour of the healthy bone or cartilage.

The virtual correction of the two- or three-dimensional image of thedamaged bone or cartilage is carried out by a comparison with images ofhealthy bones or cartilage which show shapes similar to the damagedbones or cartilage. Alternatively, a virtual correction can be conductedwith the help of an interpolation of the healthy shapes of thebones/cartilage.

The present invention also applies to an endoprosthesis which has beenmanufactured with the aforementioned method and, in particular, isadjusted to a bone/cartilage which has been prepared with one of theaforementioned devices. Alternatively, the endoprosthesis can beconnected immovably with an inventive device in order to serve assupporting surface area for the positioning of the template.

Ultimately, the present invention also applies to a surgery set forconducting knee joint surgeries consisting of femoral and/or tibialcomponents of an endoprosthesis or femoral and/or tibial components of adevice, that is, a template or implantation aid as described moreprecisely above.

Some preferred embodiments of the present invention are furtherexplained in the enclosed figures. Showing:

FIG. 1 The three-dimensional view of an inventive device with bone,

FIG. 2 a schematic cross section of the inventive device with bone,

FIG. 3 a cross section of the inventive device with bone,

FIG. 4 a three-dimensional top view of the bone with inventivegrid-shaped supports,

FIG. 5 a schematic top view of an inventive device with inventivegrid-shaped supports,

FIG. 6 a femur bone with lateral template brackets,

FIG. 7 a femur bone with template muzzle,

FIG. 8 a three-dimensional sectional view of the inventive device withtemplate muzzle,

FIG. 9 the top view of an inventive template,

FIG. 10 the three-dimensional cross section of an inventive templatewith tailored tool guides,

FIG. 11 the three-dimensional view of a tibia template,

FIG. 12 the three-dimensional partial view of the tibia template of FIG.11,

FIG. 13 the three-dimensional schematic cross section of a tool guide ofthe tibia template of FIG. 11,

FIG. 14 the three-dimensional schematic cross section on specialsupporting surface areas of the tibia template,

FIG. 15 the three-dimensional back view of a tibia template,

FIG. 16 a femur bone with marker pins,

FIG. 17 a three-dimensional top view on a template with fixing pins andbones,

FIG. 18 the three-dimensional view of a tibia template with adjustedfemur endoprosthesis,

FIG. 19 schematic bottom view of a tibia template,

FIG. 20 the view of a drilling template for tibia pins,

FIG. 21 the view of a two-dimensional tibia socket,

FIG. 22 the view of a two-dimensional tibia template,

FIG. 23 the three-dimensional view of a modified tibia template, and

FIG. 24 the three-dimensional view of a modified inventive devicewithout bones.

FIG. 1 shows the three-dimensional cross section of an inventive devicefor the resection of a femur bone 1 with several tool guides 3, 4, 5 andinventive supports 6. For the treatment of a knee joint damage, thefemur bone is generally resected in different areas. For this, the femurbone is cut off at various levels in order to cut off the abnormalcartilage or bone surface. According to an initial tool guide 3 a, 3 b,the cut surfaces are located in the coronary area and resect the thighbone 1 on the site turned towards the knee joint as well as on theopposite side. Furthermore, the inventive device shows a third toolguide 5 which is basically perpendicular to the first tool guide 3 a, 3b which is transversal to the femur bone. This tool guide serves for theinsertion of a saw for the cutting off the distal ends of the femur bone1. The second tool guides 4 a, 4 b are arranged angularly to the initialtool guide 3 a, 3 b and to the third tool guide 5 which are canthomeatal(acute-angled to the transverse plane) of the femur bone 1, preferablywith an inclination of about 45° to the third tool guide 5 which isarranged transversely.

All tool guides 3 a, 3 b, 4 a, 4 b, 5 build an immovable tool guidetemplate aligned to each other in a fixed angle which also featuresupports 6 which are shaped relatively to the tool guides for the exactattachment to the bone 1.

FIG. 2 displays a three-dimensional, schematic cross section of aninventive device, in particular a resection template 2 with coronarytool guides 3 a, 3 b and a canthomeatal tool guide 4 b, which areacute-angled to teach other and enable the preparation of certain bonesurfaces of the femur bone. Every tool guide preferably features a guidestop 27 which defines the exact immersion depth of the tool. The tool,for example a saw, is inserted into the tool guides, for example, a sawcore, which possess guidance depth D. Once the tool has overcome theguidance depth D, the cutting into the bone until resection depth dtakes place. Guidance depth D and resection depth d result in immersiondepth t of the tool. The exact adjustment of the guidance depth D to thetool guarantees that not too little and not too much bone is cut off andaccordingly the soft tissue behind the bone, such as tendons, ligamentsor blood vessels, is not damaged. The lateral core limitation of thetool additionally guarantees the very important protection of thesidebands of the knee joint during bone resection.

The manufacturing technique of the inventive resection template 2 makesit possible to manufacture the tool guides, such as the resection coresor drill holes, in exactly the lengths in which a precise immersiondepth t of the tool can be determined.

FIG. 3 displays a cross section of the inventive resection template 2with coronary tool guides 3 a and 3 b as well as canthomeatal tool guide4 b whereas whereas the cores 8 which are suitable for a saw can berecognized. Furthermore, FIG. 3 displays a fourth tool guide 7 which is,for example, appropriate for a drill which is used for undertaking anappropriate drill in the bone in order to take in support pins of theendoprosthesis. Through the hole, a recess 23 can be made in the bonewhich serves for attaching the endoprosthesis. At the same time, FIG. 3displays vertically (marked three-dimensionally on it) linear supports 6which are described in more detail below:

FIG. 4 shows the three-dimensional view onto the distal end of the femurbone 1, where the linear supports 6 can be seen. For a betterrepresentation, the other parts of the resection template 2 are notillustrated. The grid-shaped, linear supports 6 are basicallyrectangular whereas sagittal ribs 6 a and coronary ribs 6 b arebasically perpendicular to each other and display the basic structuresof the bone.

The exact positioning of the resection template 2 takes place with thehelp of a grid-shaped structure of linear supports 6. In order toachieve an optimal reproduction of the surface structure of bone 1 andin order to position the later template 2 precisely to the bone 1, forexample, a computer-tomographic image is taken which displays thedifferent layers of the bone. By means of this computer-tomographicimage, two-dimensional, linear differences in gray value can be detectedwhich mark the crossing between bones and soft tissue. Along the layeredimages, the linear supports 6 can be reconstructed by scanning andmolding the bone surface along the two-dimensional tomographic layeredimages. This rib construction has the advantage that only preciselandmarks of the bones can be depicted whereas the effort for thereconstruction of the joint surface negative is reduced significantly.Furthermore, an exact support of the resection template 2 on bone 1 canbe guaranteed because soft tissue or synovial fluid not sufficientlycaptured by computer-tomographic images can be eluded between the ribsor the ribs can be pushed easier into elevated surface areas until theyencounter the bone surface or the ribs can be pushed away from theelevated surface areas.

The rib structure schematically displayed in FIG. 4 shows FIG. 5embedded in resection template 2. Between the initial tool guides 3 aand 3 b, placed parallel to each other, the second tool guides 4 a and 4b and the third tool guides 5, the grid-shaped supporting structure 6 ofthe sagittal ribs 6 a and the diagonally-shaped coronary ribs 6 b isvisible. Two coronary tool guides 3 a 1 and 3 a 2, which are dividedfrom each other, are used for the resection of two bone humps on thedistal end of the femur bone 1.

In a computer-tomographic image of the femur, the cartilage coveringbetween both femoral condyles up to the beginning of the knee jointslide bearings is generally conserved, thus enabling arch-shapedstructures to be reconstructed by tracing of the surface in sagittaldirection, for example, in three ways, which have, for example, a widthof three layers which cause a hooking of the resection template to thebone surface. As a result, an upward sliding and a sideway sliding isprevented, this makes it possible to position template 2 precisely.

FIG. 6 shows second supports 9, for example, coronary brackets, whichcan be implemented as lateral template brackets. This serves the purposeof a defined attachment of the resection template 2 in lateral directionon the distal end of the femur bone. This provides support for thecoronary ribs 6 b which are arranged on coronary level or by the secondsupports which are displayed in FIG. 6 and built as coronary bracketsand which are constructed on the left and right side of the outer sideof the femur.

While reconstruction the second support, care has to be taken that thecoronary brackets do not come into contact with the external or internalsideband with an approximate 110° flexion of the knee joint afteropening the knee joint and everting the knee cap but to circle theepicondyl humps above and ventrally and to not reach to close to thejoint margins in order not to conflict with possible osteopyths present.In order to take the skin of the bone and the remaining mucosa intoconsideration, for example, 0.2 mm needs to be deducted from the boneside of this construction.

FIGS. 7 and 8 show a third support 10, which is shaped as a sagittalmuzzle, in order to secure the resection template 2 in sagittaldirection. Thereby, a third support, especially above the kneecap slidebearings, is manufactured, which narrows towards the top, that is,proximal. This template beak must not be too long in order not to damagethe upper recessus or musculus articularis not too much. The anchorageof the third support 10 to the resection template 2 has to be made insuch a way that the anchorage does not close up the initial coronarytool guide 3 b. The template muzzle can be constructed from an extensionof tool guide 3 b.

FIG. 9 shows the top view of the inventive device with two-part coronarytool guides 3 a 1 and 3 a 2 as well as initial coronary tool guides 3 b,arranged parallel to it but at the same time at a distance to eachother, and which are appropriate for a saw as well as two viewingopenings 11 which allow the view of the grid structure of the linearsupport 6 and the surgical area. Additionally, FIG. 9 shows fixationopenings 12 which are distally located on the template in order tointroduce fixatives.

In the special example of embodiment according to FIG. 9, on the distalarea of the resection template 2, for example, two cylindric cores, 3 to4 cm in diameter, are arranged which enable the view of the underlyingjoint area and allow to control if the templates are level with thesurface, thus, if the linear supports 6 are level with the bone surface.

A considerable complication of knee surgery is the accidental resectionof the anterior cruciate ligament. Whereas with conventional bicondularknee joint endoprosthesis, the anterior cruciate ligament is generallyresected, the anterior cruciate ligament can be preserved withindividually manufactured knee joint endoprostheses, according to thepresent invention. In order to avoid an accidental damage of thecruciate ligaments, an opening is adjusted on the femur template which,for example, has a diameter of 3 to 4 cm, is round and is in line withthe projection on the intercondylar notch. The opening gives a view ofthe anterior cruciate ligament and also gives the possibility ofprotecting the anterior cruciate ligament by using chirurgicalinstruments at each resection. Additionally, this opening gives a viewof the positioning of the ribs, of the so-called notch hook and alsopartly on the supports 6 of the margin of the under femoral condyle.

According to FIG. 10, the tool guides 3, 4, 5, 7, 14 can be alsotailored in order to avoid a displacing of the template on the opensitus by lateral everted soft tissue. The tailoring should be made onthe side of the knee joints and the soft tissue in order to avoid adisplacing of the template.

Furthermore, the invention also applies to a tibia template,schematically displayed in FIG. 11, with fifth tool guides 14 a1 and 14a2 which are separated from each other as well as a coronary tool guide3 and a transversal tool guide 5. Also, the linear supports 6 as well asthe fixation guides 12 for the fixing of the template to the bone areindicated. By the use of these fixation guides 12, for example, nails orscrews can be guided in order to guarantee the support of the template.The precise positioning and adjustment of the template takes place bymeans of the linear supports 6, though.

The supports 6 can also be featured as grid structure, as displayed inFIG. 12, whereas the sagittal ribs 6 a and the coronary ribs 6 b buildthe grid structure which are arranged preferably rectangular to eachother. In this regard, it is important to approximate the supports 6 asclose as possible to the intercondylar humps in order to achieve acertain lateral stabilization.

Equally, in FIG. 11 a bridge 15 is displayed which leads to a supportingsurface area 16 which can be arranged punctually, if necessary, or—asdisplayed in FIG. 11—flat, whereas it is not a template bracket with aso-called tibia bow which is situated from the surgical situs towardsthe outside and presses the supporting area on the intact, skin-coveredsurface of the tibia. Therefore, a rotation of the tibia template 2along the lateral axis and the vertical axis in an anteroposteriordirection as well is prevented.

In this version of the invention, a resection of the tibia takes placewith the help of a template according to FIG. 11, whereas the openingfor the femoral condyle needs to be proceeded further. In the secondstep, a template, which is a combination of FIG. 1 and FIG. 2, ismanufactured, and presents a polyamide model of the tibia component ofthe endoprosthesis and is linked inseparably to a saw guide for theresection on the thigh bone, whereas with one of the initial templates,only the cut on the thigh bone in extension position and at a distancefrom the body (distal) is permitted, and with a second template, onlythe rearward (dorsal) cut on the femoral condyle in flexion position ispermitted.

According to the above mentioned method (femur first), the axis (inextension position) is adjusted initially and subsequently, theligamentous tension (in extension and flexion position) is balanced.Subsequently, with an appropriate third template, the so-called foldingcuts are performed and thus, the resection of the thigh bone iscompleted.

This method (tibia first) is also appropriate for the implantation ofstandardized endoprostheses because a lower leg component (a tibiaplateau) can be inserted without the need of adjusting it completely tothe surface contour of the original tibia plateau.

With the “femur first” method, a similar device for the tibia—used as“tibia stopper” (but as a straight, horizontal limitation passing beforethe tibia bone, for example, in the shape of a cylindric rod)—candisplay the precise extension position of the knee joint which has beenfixed pre-operatively on the image data instead of the sleeve-likesupport adapted to the shinbone which is inseparably attached to thethigh template.

This is helpful in cases where a more or less large degree of extensiondeficits of the knee joint due to ligament shortening is present. Theseextension deficits are solved with the compensation of the ligamentoustension, in full or in part, and thus, a changed position of theextension position compared to the position at the time of imaging isthe result. The straight shape of this tibia support permits a swingingof the lower leg at the adjustment of the leg axis and at the correctionof the ligamentous tension in contradiction to the sleeve-shapedsupport.

Additionally, a third support 10 can be intended as a so-called tibiaplate which is constructed as a bracket-like support on the front edgeof the tibia in order to guarantee a precise locating and positioning ofthe resection template 2 in anteroposterior direction. The third support10 should be molded medially next to the tibia hump, as far as possible,in order to avoid a lateral rotation in lateral position of the template2 around the vertical axis and to guarantee a positioning around thevertical axis as precisely as possible. In order to examine the leveledposition of the third support 10 conducted as tibia plate, an openingmedial to the tuberositas tibia can be attached.

FIG. 13 displays the lateral tailoring 13 of a tool guide of the tibiatemplate in order to avoid a movement of the template caused bylaterally everted soft tissue. Furthermore, according to FIG. 14, it ispossible to mold the rearward side of the tibia template by a support 17in such a way that it corresponds exactly to the resected surface of thedistal end of the femur 1 which is located in a 110° flexion positionclose to the tibia bone. This supports an exact positioning of theresection template 2 on the tibia bone. It is possible because the jointspace is very narrow by preservation of the anterior cruciate ligamentand the tibia template could otherwise be moved by the femur ventral.

FIG. 15 shows the schematic top view of the tibia template with 15sagittally adjusted tool guides 14 a1 and 14 a2 as well as a transversaltool guide 5, whereas sagittal canals 18 are provided which enable theuse of appropriate Kirschner's wires or Steinmann's nails to aninterface between the vertical resection level at the intercondylarhumps and the horizontal resection area on the tibia plateau. This notonly enables an additional fixation of template 2 on bone 1 but alsoprevents an accidental sawing too deep inside the so-calledintercondylar humps during the horizontal resection or a very deepsawing inside the tibia head during the vertical resection. It wouldcause a significant complication because generally, a fracture of theintercondylar hump or a fracture of the inner or outer kneecap bracketwould be the result. In order to guarantee an exact positioning of theresection template 2, additional fastening means 19 or fastening areas20 can be attached to the bone 1, according to FIG. 16, such as markers,like screws, Kirschner's wire or pins, which can be inserted into theappropriate template mounting when adjusted to the bone.

FIG. 17 shows the implementation of appropriate fastening means 19 byappropriate openings of the resection template 2.

FIG. 18 displays the three-dimensional top view of an inventiveresection template 2, a tibia template in particular, which is molded toan endoprosthesis 21. The embodiment of the present invention is usedfor the exact positioning of the tibia template towards the prospectiveimplanted femur prosthesis 21. One end of template 2 represents areproduction of the femur prosthesis 21 which features pins 22 for theinsertion in, for example, recesses 23 as displayed in FIG. 3. After theresection of the femur, the tibia template which is molded asendoprosthesis 21 is adapted to the femur similar to femur prosthesisand, after full extension and exact positioning of the tibia accordingto the Mikulic'z-line and after fixation of bone 1, is attached to thetemplate 2 with the help of Kirschner's wires. This enables a preciseresection of the tibia even without fastening means 19, such as markerscrews.

FIG. 19 displays the three-dimensional view of a resection template 2which features a guiding aid 24 besides the third support 10 which, forexample, is a guiding aid for a measuring stick for the precisedetermination of the Mikulic'z-line whereas this guiding aid runsthrough the proximal part of the tibia template, in particular. Theguiding aid 24 in shape of a hourglass drill runs in vertical directionand its narrowest position stands exactly in front of the knee jointfocus, so that after inserting a long measuring stick or measuring tape,a straight line between the focus of the femur head, the knee jointfocus and the focus of the ankle joint can be identified.

FIG. 20 shows a drill guide 26 which is featured in a tibia template 25which, for example, is for the attachment to the resected bone. Forexample, after removal of the femoral tibia template 2, the anteriorpart of the intercondylar hump needs to be resected with the oscillatingsaw and the edges need to be smoothed with a round file, so that thefront bracket between both plateaus of the tibia frame can be movedforward to the tibia plateau that a precise adjustment of the tibiaframe on the resected tibia bone is guaranteed. On this occasion,corrections of the fit of the tibia frame can be made, for example,smaller corrections with the use of a straight file on the front orlateral edges of the intercondylar hump. With the help of the drillholes of the template, the anchoring canals for the pins of the tibiaplate can be drilled, eventually.

FIG. 21 displays an alternative, which is, a two-part tibia frame withpins 22 which can be implanted, so that a resection of the central partof the intercondylar hump is unnecessary. However, the tibia template 25needs to consist of two parts as well according to the tibia frame 28which are connected with a brace 29, running in front of theintercondylar humps. FIG. 22 displays the embodiment of drill guides 26.

At implantations with the preservation of the anterior cruciateligament, i. e. implantations of individual endoprosthesis, there isgenerally not enough space for implementing the vertical stops at thetibia without damaging the femur or cutting too deep into the tibia. Thepreservation of the anterior cruciate ligament always means confinedspace in the joint lines during surgery because the anterior cruciateligament prevents a sliding of the tibia towards the femur. Furthermore,with the use of the resection template 2, the knee joint is kept inextension position which means an additional narrowing of space.

For this purpose, the resection template 2, as shown in FIG. 11, ismodified by excluding the bridge 15 and all tool guides as far as thetransversal, third tool guides 5. Subsequently, the horizontal steps canbe taken. Afterwards, the tool guides 3, 14 a 1, 14 a 2 for the verticalcuts on the tibia, are attached with the help of a further modifiedresection template 2′, as shown in FIG. 23. The transversal, third toolguides 5, which are also shown, can also be excluded from the modifiedresection template 2′ (not shown in FIG. 23). Because of the possibleflexion of the knee joint and the non-support of the prosthesisimitation in the resection areas of the femur, as displayed in FIG. 18,the joint has more flexibility and sufficient space in order toguarantee the vertical cuts without additional damage of the bonestructure.

The attachment of the modified resection template 2′ on the tibia,according to FIG. 23, can additionally be made with two insertion-styleplates 30, which are inserted into the horizontal resection gaps whichare already prepared. This enables an even more precise positioning.

FIG. 24 displays the three-dimensional view of a modified inventivedevice without bone for the revision surgery. Generally, after 10 to 12years, a loosening of the prosthesis takes place. In these cases, theold prosthesis needs to be removed, a new implant socket needs to becreated and a bigger, new prosthesis, as appropriate, needs to beimplanted. Despite the loosening of the old prosthesis, after removal ofthe old prosthesis the implant socket basically remains the same asbefore the initial implantation, so, according to FIG. 24, anothermodified template 2″ can be leveled to the old implant socket. Inaccordance with the invention, appropriate supports 6 are provided butbecause of the smooth surface of the implant socket not absolutelyessential. The modified template 2″ shows only tool guides for sawblades which enable an appendectomy of, for example, 2 mm on each levelof the implant socket. Thus, a new implant socket for conventional oreven individually manufactured alteration prosthesis can be preparedprecisely and in a time and/or bone saving way.

1. A device for the resection of bones to prepare for the attachment ofan endoprosthesis to joints comprising at least two joint elementscooperating with each other, comprising at least one tool guide and atleast one support suitable for orienting the at least one tool guide,wherein, either in the immediate vicinity of the joint and/or acrossjoints, the at least one support enables the at least one tool guide tobe oriented and positioned at the same joint element or enables the atleast one tool guide to be oriented and positioned at the same jointelement distally to the area to be treated and/or outside the surgicalarea.
 2. The device according to claim 1, wherein at least one supportconsists of a three-dimensional reconstruction of the prosthesiscomponents which need to be implanted or of a support which is situatedon the surgically opened tibial plateau on the skin and the periosteumabove the intact, distal edge of the shinbone.
 3. The device accordingto claim 1, wherein besides at least one support another punctual orlinear support is molded according to two- or three-dimensional imagesof the bone which needs to be prepared whereas the lineshape of thesupport is molded along longitudinal defined surface structures of thebone and/or the punctual shape of the support according to specialfeatures of the bone in accordance with the two- or three-dimensionalimages.
 4. The device according to claim 1, wherein several initiallinear supports are located in several initial, basically parallellevels which are distanced from each other and several second linearsupports are located in several second parallel levels which aredistanced from each other and at the same time, the several initial andsecond levels are not parallel to each other but basically rectangularto each other.
 5. The device according to claim 1, wherein severalgrid-shaped, linear supports and several tool guides angular to eachother build a template whereas the supports and the tool guides aremolded from one form or made from a material in such a way that thetemplate is molded seamlessly from one piece whereas the templatefeatures view openings and/or fixation openings.
 6. A method for themanufacturing of a device for the resection of bones, with at least onetool guide and at least one support suitable for orienting the at leastone tool guide, with the following steps: a) Preparation of two- orthree-dimensional images of the bone which needs to be prepared, b)Determination of punctual and/or linear contours of the bone at the two-or three-dimensional images, c) Determination of areas which need to beprepared and selection and positioning of at least one tool guide and d)Manufacture of a template with at least one support which enables the atleast one tool guide to be oriented and positioned at the same jointelement or enables the orientation or positioning of the at least onetool guide distally to the location to be treated and/or outside thesurgical area at the same joint and to the at least one tool guide whichis positioned and located relatively to the support.
 7. The methodaccording to claim 6, wherein several, grid-shaped linear supports andseveral tool guides angular to each other are determined with the helpof two- or three-dimensional images of the bone which needs to betreated and are saved in a three-dimensional data record in order tomanufacture the template whereas, in accordance with thethree-dimensional date-record, the supports and tool guides are moldedfrom one form or made from a material in such a way that the template ismolded seamlessly from one piece.
 8. A method for the manufacturing ofan endoprosthesis or for the manufacturing of a support for locating andpositioning of the at least one tool guide to another joint element forattachment to a bone, which has been prepared with a device according toclaim 1, in particular, with the following procedures: a) Preparation oftwo- or three-dimensional images of the bone which needs to be prepared,b) Determination of areas which need to be prepared and selection andpositioning of at least one area which needs to be removed from thebone, c) Virtual correction of the two- or three-dimensional images foran adjustment of the contours of the bone to the contours of a healthybone, and d) Manufacture of an endoprosthesis or support on the basis ofthe bone areas which need to be prepared and the virtual correction ofthe two- or three-dimensional images.
 9. The method according to claim8, wherein the virtual correction of the two- or three-dimensional imageof the damaged bone is carried out by a comparison with images ofhealthy bones which show similar shapes to the damaged bone. 10.(canceled)
 11. (canceled)